FDA Clears AngioDynamics’ Thrombus-Reducing Ports

AngioDynamics, Inc. has announced the U.S. FDA 510(k) clearance through its subsidiary business Navilyst Medical Inc., for its BioFlo Port with Endexo technology, which is designed to reduce the accumulation of catheter-related thrombus on, and in, the port catheter.

Background

Implantable ports are medical devices implanted under the skin that facilitate long-term delivery of medication and access to a patient’s vascular system for repeated intravenous treatments such as chemotherapy, blood withdrawal or delivery of total parenteral nutrition. Medical device thrombosis caused by products such as ports costs the U.S. healthcare system an estimated $1 billion annually with over 50,000 deaths per year caused by thromboembolism and cancer patients among those most susceptible to thrombosis.

AngioDynamics Inc. describes itself as a leading provider of innovative, minimally invasive medical devices for vascular access, surgery, peripheral vascular disease and oncology. Its BioFlo Port is the only port manufactured with Endexo technology, a permanent and non-eluting integral polymer, designed to provide more resistance to the accumulation of platelets and thrombus.

According to AngioDynamics’ press release, BioFlo technology shows promise in decreasing the accumulation of catheter-related thrombus without incorporation of heparin, antibiotics or antimicrobials, or any other transient materials typically associated with coated or impregnated technologies. In-vitro blood loop model test results show that on average the BioFlo Port catheter had 96% less thrombus accumulation on its surface compared to non-coated conventional port catheters, based on platelet count. The BioFlo Ports are also available with PASV Valve Technology, AngioDynamics’ patented valve designed to automatically resist backflow and reduce blood reflux on the inside of the catheter.

Company comments

“We’re pleased to build on the success of our BioFlo PICC by introducing the first port with a demonstrated reduction in thrombus accumulation(1,2) ,” said Joseph M. DeVivo, President and CEO of AngioDynamics. “The introduction of BioFlo ports is consistent with our plan to bring disruptive technologies into the Vascular Access space and reflects the strengthening of our BioFlo platform.”

“We’re pleased to have received BioFlo Port clearance ahead of our expected schedule and plan to launch BioFlo ports during the third fiscal quarter of 2014, bringing a financial impact to the second half of FY14.” said Chuck Greiner, Vice President of the Global Vascular Access Franchise. “Given the strong performance we continue to see in BioFlo PICCs since our worldwide launch, we are excited to expand this premium technology into other segments. We will continue to grow our BioFlo vascular access portfolio by seeking FDA clearance for BioFlo dialysis catheters.”